NCT02657902

Brief Summary

The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

6 years

First QC Date

January 8, 2016

Last Update Submit

January 15, 2016

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • Cutout rate

    Differences in the Cutout rate of the femoral head screw with/without U-Blade antirational screw

    3 months after intervention

Secondary Outcomes (1)

  • Mobility

    3 months after intervention

Study Arms (2)

Gamma 3 Nail

Fractures that were treated with a Gamma 3 nail

Procedure: Fractures were treated with a Gamma 3 intramedullary nail

Gamma 3 Nail + U-Blade

Fractures that were treated with a Gamma 3 nail and additional with antirotation U-blade lag screws.

Procedure: Fractures were treated with a Gamma 3 intramedullary nail + U-Blade

Interventions

Fractures were treated with a Gamma 3 intramedullary nailPROCEDURE
Gamma 3 Nail
Fractures were treated with a Gamma 3 intramedullary nail + U-BladePROCEDURE
Gamma 3 Nail + U-Blade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)

You may qualify if:

  • OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)

You may not qualify if:

  • Patients with pathological fractures
  • Patients treated with a long gamma nail were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 18, 2016

Study Start

January 1, 2009

Primary Completion

January 1, 2015

Last Updated

January 18, 2016

Record last verified: 2016-01